Pharmacyclics, Inc

Pharmacyclics, Inc Drugs

• Imbruvica
  

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  Imbruvica

  

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  2.1 Dosing Guidelines

  Administer IMBRUVICA orally once daily at approximately the same time each day. Swallow the capsules whole with water. Do not open, break, or chew the capsules.

  2.2 Dosage

  Mantle Cell Lymphoma

  The recommended dose of IMBRUVICA for MCL is 560 mg (four 140 mg capsules) orally once daily.

  Chronic Lymphocytic Leukemia and Waldenström's Macroglobulinemia

  The recommended dose of IMBRUVICA for CLL and WM is 420 mg (three 140 mg capsules) orally once daily.

  2.3 Dose Modifications for Adverse Reactions

  Interrupt IMBRUVICA therapy for any Grade 3 or greater non-hematological, Grade 3 or greater neutropenia with infection or fever, or Grade 4 hematological toxicities. Once the symptoms of the toxicity have resolved to Grade 1 or baseline (recovery), IMBRUVICA therapy may be reinitiated at the starting dose. If the toxicity reoccurs, reduce dose by one capsule (140 mg per day). A second reduction of dose by 140 mg may be considered as needed. If these toxicities persist or recur following two dose reductions, discontinue IMBRUVICA.

  Recommended dose modifications are described below:

  Toxicity Occurrence MCL Dose Modification After RecoveryStarting Dose = 560 mg CLL and WM Dose Modification After RecoveryStarting Dose = 420 mg First Restart at 560 mg daily Restart at 420 mg daily Second Restart at 420 mg daily Restart at 280 mg daily Third Restart at 280 mg daily Restart at 140 mg daily Fourth Discontinue IMBRUVICA Discontinue IMBRUVICA

  2.4 Dose Modifications for Use with CYP3A Inhibitors

  Avoid co-administration with strong or moderate CYP3A inhibitors and consider alternative agents with less CYP3A inhibition.

  Concomitant use of strong CYP3A inhibitors which would be taken chronically (e.g., ritonavir, indinavir, nelfinavir, saquinavir, boceprevir, telaprevir, nefazodone) is not recommended. For short-term use (treatment for 7 days or less) of strong CYP3A inhibitors (e.g., antifungals and antibiotics) consider interrupting IMBRUVICA therapy until the CYP3A inhibitor is no longer needed [see Drug Interactions (7.1)].

  Reduce IMBRUVICA dose to 140 mg if a moderate CYP3A inhibitor must be used (e.g., fluconazole, darunavir, erythromycin, diltiazem, atazanavir, aprepitant, amprenavir, fosamprevir, crizotinib, imatinib, verapamil, and ciprofloxacin) [see Drug Interactions (7.1)].

  Patients taking concomitant strong or moderate CYP3A inhibitors should be monitored more closely for signs of IMBRUVICA toxicity.

  2.5 Dose Modifications for Use in Hepatic Impairment

  For patients with mild liver impairment (Child-Pugh class A), the recommended dose is 140 mg daily (one capsule). Avoid the use of IMBRUVICA in patients with moderate or severe hepatic impairment (Child-Pugh classes B and C) [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

  2.6 Missed Dose

  If a dose of IMBRUVICA is not taken at the scheduled time, it can be taken as soon as possible on the same day with a return to the normal schedule the following day. Extra capsules of IMBRUVICA should not be taken to make up for the missed dose.

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